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Generated: November 17, 2018

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Details for New Drug Application (NDA): 018081

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NDA 018081 describes DEPAKENE, which is a drug marketed by Abbvie and is included in two NDAs. It is available from two suppliers. Additional details are available on the DEPAKENE profile page.

The generic ingredient in DEPAKENE is valproic acid. There are seventeen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the valproic acid profile page.
Summary for 018081
Tradename:DEPAKENE
Applicant:Abbvie
Ingredient:valproic acid
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018081
Medical Subject Heading (MeSH) Categories for 018081
Suppliers and Packaging for NDA: 018081
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEPAKENE valproic acid CAPSULE;ORAL 018081 NDA AbbVie Inc. 0074-5681 0074-5681-13 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0074-5681-13)
DEPAKENE valproic acid CAPSULE;ORAL 018081 NDA REMEDYREPACK INC. 70518-1459 70518-1459-0 30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (70518-1459-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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